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• Participants must complete the entire presentation/seminar to achieve successful

completion and receive contact hour credit. Partial credit will not be given.

• All of the presenters are employees of STERIS Corporation and receive no direct

compensation other than their normal salaries for participation in this activity.

• STERIS Corporation is an approved provider of continuing nursing education by

the California Board of Registered Nursing, provider number CEP 11681 for 1

contact hour along with IAHCSMM and CBSPD.

• STERIS Corporation is providing the speakers and contact hours for this activity.

However, products referred to or seen during this presentation do not constitute a

commercial support by the speakers.

Continuing Education Contact Hours

Learning Objectives

After completing this continuing education activity, the participant

should be able to:

• Describe the various activities performed by healthcare professionals

working in sterile processing departments

• Review the key steps that should be performed when conducting an

assessment of sterile processing activities in a healthcare facility

Importance of Sterile Processing

• Central hub of healthcare facility

• Efforts effect virtually every patient in facility

Challenges of Sterile Processing

• Low priority and misunderstood

• Time demands

• Intimidation

• No formal sterile processing education

When is it a good time

to learn about sterile

processing in your

facility?

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Setting the Stage

• The phone call…

• Suspected sterilization failure

• Physician notification

• Patient surveillance

Start Now

• Gather information

• Standardization (P&Ps, products, practices)

• Ask questions

Understand the Flow Point of Use

• OR, L&D and Clinics

• At point of use

Separate disposable from

reusable, including sharps

Keep instruments moist

Decontamination Delay

• Delays in transport

Dried debris difficult to clean

Development of biofilm

Damage to passivation layer

of surgical instruments

Biofilm Development

Containment During Transport

―Containment may be accomplished by any means that adequately

prevents personnel contact with contaminated items during

transfer‖ — AAMI ST79:2010

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Remote Decontamination

Perform decontamination activities only in areas that can support

good work practices

• Personal Protective Equipment (PPE)

• Appropriate equipment/space

• Separation of dirty and clean processes

Physical Environment

Traffic Patterns

Lighting Ventilation

Controlled Environment

Work Area Temperature Humidity

Decontamination 60°F and 65°F

(16°C and 18°C) 30 – 60%

General Work Areas 68°F and 73°F

(20°C and 23°C) 30 – 60%

Preparation & Packaging 68°F and 73°F

(20°C and 23°C) 35 – 50%

Sterile Storage & Personnel Support Areas May be as high

as 75°F (24°C) ≤ 70%

Equipment Access Rooms 75°F and 85°F

(24°C and 29°C) 30 – 60%

Controlled Environment

• Monitor temperature and humidity

• Out of range leads to:

Noncompliance with PPE

Promotion of bacterial growth

Altered performance of sterilization monitoring products

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Smooth Surfaces

• Floors, walls, ceilings

• Work surfaces

• Compatible with cleaning

chemicals

Work Flow

―The decontamination area should be physically separated from

all other areas of processing department…‖ — AAMI ST79:2010

Emergency Eyewash Equipment

• Accessible within 10 seconds of potential exposure

• Strong chemicals: unit should be immediately adjacent

to the hazard

• Check and log eyewash equipment once/week

American National Standards Institute document EMERGENCY EYEWASH & SHOWER EQUIPMENT, 1998

OSHA 29CFR 1910.133 – Eye & Face Protection, and CFR 1910.151 – Medical & First Aid Standard

Emergency Eyewash Equipment

• Hands free

– Bottle type not recommended

• 15 minutes of continuously free-

flowing water

• Disable hot water

Hand Washing

• Hand washing sink separate from decontamination sinks

• Hands-free equipment

• Alcohol waterless agents

Housekeeping

• Daily cleaning/disinfection of

floors and horizontal surfaces

• Sequence cleaning from

clean → dirty

• Keep separate cleaning

supplies

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Decontamination

Two step process

• Begins with cleaning

• Followed by microbicidal process

– Disinfection

– Sterilization

Decontamination Process

Cleaning

• First and most important step

• Thorough cleaning can remove of bioburden

Microbicidal Processes

• Designed to provide a particular level of lethality (kill)

• Depending on the level of decontamination disinfection or

sterilization may be used

Personal Protective Equipment

Manual vs. Automated Cleaning

Manual Cleaning

• First: soak

• Second: wash

• Third: rinse/treated water

Manual Cleaning

• Heat and moisture sensitive devices

• Not a disinfection process

• Wear gloves in prep and pack

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Cleaning Brushes

• Quantity in sizes

• Replace when worn

• Cleaned/disinfected daily

• Metal bristle brushes

Mechanical Washers

Open, Disassemble Instruments Organize Instruments

Instrument Detergents, Disinfectants

• Compatible with devices

• Remove inappropriate chemicals

• MSDS

• Follow manufacturer instructions

Ultrasonic Cleaning

• Sonic energy creates tiny bubbles

Bubbles become unstable, then implode

Dislodges soil from instrument crevices

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Instrument Lubrication

• Automated

• Manual

Follow manufacturers instructions

Label and date

Assembly Area

• Instrument Inspection

Clean

Working order

Assembly Area

Instrument tray assembly

• Count sheets

• Content distribution

• Weight limits

Packaging

• Peel pouches

• Sterilization wrap

• Rigid sterilization containers

Peel Pouches

• Light weight

• Materials appropriate for sterilization technologies

Steam – paper

Hydrogen peroxide gas plasma and Ethylene Oxide

Ozone

Peel Pouches

• Seals

• Double pouching

Inside pouch smaller than outside pouch

Inner pouch should not be folded over onto itself

• Written labels on plastic side only

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Sterilization Wrap

• Woven wrap

Launder and inspect

• Non-woven

Single layer

One-step wrap

Rigid Containers

• Durable packaging

• Plastic composite or anodized aluminum

• Variety of designs

Rigid Containers

• Inspect for damage

• Cleaned after each use

Compatible chemistries

• Stacking

Instrument Sets Placed Flat

NO

YES

Loading the Sterilizer Cart

• Do not overload

• Basins positioned for drainage

• Packages should never contact

sterilizer chamber walls

Sterilization

• Testing requirements

• Monitoring practices

• Record keeping practices

• Failure investigation

• Extended cycles

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Equipment Monitoring

• Routine maintenance

• Preventative/breakdown maintenance

• Maintenance records

Routine Monitoring

• Bowie-Dick air removal test

Prevacuum cycles

• Biological testing

• Other testing

Following installation, relocation or major repairs

Bowie-Dick Test

Air Removal Test

• Test results must be negative

Conventional Biological Indicator Strips

Spore Suspension

Glassine Envelope

Adhesive Seal

Filter Paper Carrier

Spore Suspension

Glassine Envelope

Adhesive Seal

Filter Paper Carrier

Filter Paper Carrier

Spore Suspension

Conventional Self-Contained Biological Indicator

Spore Suspension

Cap

Vial

Media Ampoule

Filter Paper Carrier

Spore Bar

Enzyme-Based Early-Readout

Cap

Vial

Media Ampoule

Media containing Alpha Glucosidase

with attached 4-Methylumbelliferyl

Filter paper carrier with spores

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Comparison

Utilizes nutrients,

grows and replicates

Waste builds

changing pH making

media turn yellow

Conventional

Spore Enzyme works

on modified nutrient,

by-product glows

Bacteria replicates Waste builds changing pH

making media turn yellow

Enzyme-based Early-readout

Biological Monitoring

• Conventional BI can be used for all monitoring

BI challenge test pack

Self-contained BI test

• Enzyme response cannot be used for verification

Installation/major repair monitoring

Periodic product testing

Chemical Indicators

• Visual identification of processed packs

• Verification of sterilant penetration

• Air removal verification of prevacuum sterilizers

• Load monitoring and load release

Chemical Indicator

• Six classes

• FDA recognizes only Classes 1, 2 and 6

• Each class has different performance specifications

Chemical Indicators

Class 1:

• External indicators

• Shows exposure to sterilization

process

• Indicates processed and

unprocessed items

Chemical Indicators

Class 2:

• Indicators used in specific tests

Bowie-Dick Test

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Chemical Indicators

Class 3:

• Internal indicators

• Single-parameter indicators

• Not frequently used for steam sterilization cycles

Chemical Indicators

Class 4:

• Internal indicators

• React to two or more critical parameters

Chemical Indicators

Class 5 – Integrators:

• Internal indicators and challenge packs

• Respond to all critical parameters

• Performance correlated to the BI

• For gravity and pre-vacuum cycles

Chemical Indicators

Class 6 – Emulating Indicator:

• Internal indicators and challenge packs

• Respond to all critical parameters

• Performance correlated to sterilization cycle – tighter tolerance

• For gravity and pre-vacuum cycles

Pack Control

Internal Monitoring

• Placed into every set/pack/container

• Placed in most difficult area

• Confirm penetration of sterilant

Process Control

Lot control label

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Load Release (Non-Implant Loads)

At the end of the cycle

• Review cycle print out tape

• Review external chemical indicator

Load Release (Loads with Implants)

At the end of the cycle

• Review cycle print out tape

• Review external chemical indicators

• Review BI results

• Quarantine load until the results of the BI testing are available

(AAMI, 2010)

Early Release and Exemption Form Record Keeping

Post Sterilization

• Place loading carts:

Low traffic areas

• Handle when completely cool

• Inspect package integrity

Storage of Sterile Items

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Handling and Distribution

Transport sterile/clean in controlled environments

Product Recalls

• In the event of a recall

Recall all items from affected loads

Reprocess all items

• Clear, written policies and procedures

Action Plan

• Survey sterile processing departments routinely

Standards compliance

Industry recommended practice compliance

• Approach systematically

• Collaboration between departments

Evaluation and Registration

• Thank you for attending this CE activity

• Please complete and submit the evaluation form

• For more information on the CE credentialed programs

offered, go to http://university.steris.com

References

• Association for the Advancement of Medical Instrumentation (AAMI), Comprehensive Guide

to Steam Sterilization and Sterility Assurance in Health Care Facilities, ANSI/AAMI

ST79:2010. Arlington (VA): AAMI, 2010. American National Standard

• Association for the Advancement of Medical Instrumentation (AAMI), Containment Devices for

Reusable Medical Device Sterilization, ANSI/AAMI ST77:2006. Arlington (VA): AAMI, 2006.

American National Standard

• American National Standards Institute document, ―Emergency Eyewash & Shower

Equipment,‖ 1998

• Occupational Safety and Health Administration (OSHA). Medical & First Aid Standard. Code

of Federal Regulations, Title 29, Part 1910.133

• Occupational Safety and Health Administration (OSHA), Eye and Face Protection Standard.

Code of Federal Regulation,. Title 29, Part 1910. 151

References

• Perkins, John J., Principles and Methods of Sterilization in Health Sciences, Second Edition,

eighth printing, 1983, p. 246-248

• Preparing Instruments, Utensils, and Textiles for Sterilization and Wet Pack Problem Solving

Guide, STERIS Corporation, 2003

• Sterilization of Health Care Products – Chemical Indicators – Part 1 General Requirements,

EN ISO 11140-1:2005

• International Association of Healthcare Central Service Materiel Management, Central Service

Technical Manual. 4th, Chicago IAHCSMM, 2008